It aims to make the procedure for granting consent for the deliberate release* and placing on the market of genetically modified organisms (GMOs)* more efficient and more transparent.

It also limits that consent to a period of 10 years (renewable) and introduces compulsory monitoring after GMOs have been placed on the market.

KEY POINTS

This directive provides for:

a system for assessing case-by-case the environmental risks associated with releasing GMOs;

common objectives for monitoring GMOs after their deliberate release on the market; and

a mechanism that modifies, suspends or terminates deliberately released GMOs once information regarding the risks of releasing becomes available.

GMO labelling and public consultation is made compulsory. The European Commission is obliged to consult the competent scientific committees on any question affecting human health or the environment.

Registers must be established for the purpose of recording information on genetic modifications in GMOs alongside their location. Rules on the operation of these registers are laid down in Decision 2004/204/EC.

The Commission must publish a report on the experience of GMOs placed on the market and a summary of the measures taken by EU countries to implement this directive every 3 years.

Although this directive allows EU countries to restrict or prohibit the release of GMOs that constitute a risk to human health and the environment, Directive (EU) 2015/412 amends it allowing for EU countries to prohibit or restrict GMOs that have been authorised or are under authorisation at EU level on wider grounds. These grounds that can be used by EU countries include town and country planning, land use, socio-economic impacts, co-existence* and public policy.

The amending directive also establishes the set of deadlines and responsibilities governing the decisions taken concerning the adjustment of the geographical scope of the authorisation, including a right to opt out based on new objective circumstances.

As of 3 April 2017, EU countries in which GMOs are cultivated have to introduce measures in border areas of their territory with the aim of avoiding possible cross-border contamination into neighbouring EU countries in which the cultivation of those GMOs is prohibited, unless such measures are unnecessary in the light of particular geographical conditions.

FROM WHEN DOES THIS DIRECTIVE APPLY?

It has applied since17 April 2001. EU countries had to incorporate it into their national law by 17 October 2002.

BACKGROUND

This directive is only one of the several building blocks of the EU’s legal framework for GMOs. The other building blocks are directives and regulations (focusing on issues like genetically modified food or transboundary movements of GMOs) that work to protect human and animal health and the environment, put in place harmonised procedures, and ensure the traceability of GMOs placed on the market.

Deliberate release: in the context of this legislation, any intentional introduction into the environment of GMOs without specific containment measures.

Genetically modified organisms: using techniques of modern biotechnology called gene technology, the genetic make-up of living cells and organisms can be modified. This allows man to breed plants and animals which can, for example, have a higher yield or resist disease.

Coexistence: the existence of genetically modified, conventional and organic crops requires rules to ensure that that they can be kept segregated from one another during cultivation, harvest, transport, storage and processing.

MAIN DOCUMENT

Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC - Commission Declaration (OJ L 106, 17.4.2001, pp. 1-39)

The successive amendments to Directive 2001/18/EC have been incorporated into the basic text. This consolidated version is of documentary value only.

RELATED DOCUMENTS

Commission Decision 2004/204/EC of 23 February 2004 laying down detailed arrangements for the operation of the registers for recording information on genetic modifications in GMOs, provided for in Directive 2001/18/EC of the European Parliament and of the Council (OJ L 65, 3.3.2004, pp. 20-22)

Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ L 268, 18.10.2003, pp. 1-23)

Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (OJ L 268, 18.10.2003, pp. 24-28). See consolidated version.

Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms (OJ L 287, 5.11.2003, pp. 1-10)